NCT00170534

Brief Summary

The specific aim of this study is to complete an ongoing randomized controlled trial of the efficacy of behavioral intervention compared to STI treatment/HIV counseling alone in decreasing risk behavior and incident HIV/STI infections in Mumbai, India.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,892

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

August 27, 2010

Status Verified

April 1, 2009

First QC Date

September 12, 2005

Last Update Submit

August 26, 2010

Conditions

Sexually Transmitted Infection

Keywords

India, male, sexually transmitted infection, STI, STD

Interventions

BehaviorBEHAVIORAL

Eligibility Criteria

Age16 Years+
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Males, over 16 years of age
  • Hindu or Marathi speakers
  • Have no plan to move permanently out of Mumbia in the following 12 months
  • have a symptom of an STI or have had a sexual exposure in the past 6 months. A sexual exposure is defined as having sex with a commercial sex worker (FSW), having unprotected sex with anyone, male or female, or if the patient came to the clinic seeking an HIV test.
  • Patients will be required to provide an address that can be located by a tracer.

You may not qualify if:

  • \. HIV positive subjects.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lokmanya Tilak Municipal General Hospital

Mumbai, 400022, India

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

October 1, 2004

Study Completion

April 1, 2007

Last Updated

August 27, 2010

Record last verified: 2009-04

Locations

IN(1)